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Wolford v. Bayer Corp.

United States District Court, E.D. Kentucky, Southern Division

November 27, 2017

BAYER CORPORATION, et al., Defendants.

          OPINION & ORDER


         This matter is before the Court on a motion to remand to Pike County Circuit Court filed by plaintiffs (DE 22). The plaintiffs have also requested a hearing with this Court in connection with their motion to remand (DE 31). For the following reasons, plaintiffs' motion to remand (DE 22) is GRANTED and plaintiffs' motion for hearing (DE 31) is DENIED.

         I. Background

         Four plaintiffs originally filed this civil suit in Pike Circuit Court on September 22, 2016 (DE 1-1, at 7). Of the four original plaintiffs, only two remain: Saranda Wolford and Sheila Taylor. See (DE 28, 41). The plaintiffs have joined five defendants: Bayer Corporation, Bayer Healthcare LLC, Bayer Essure, Inc., (f/k/a Conceptus, Inc.), and Bayer Healthcare Pharmaceuticals, Inc. (collectively herein called the “Bayer defendants”), and Pikeville Medical Center (“PMC”). The defendants filed a notice of removal to this Court on October 17, 2016 (DE 1). In that notice, the defendants argue that this Court has both federal question and diversity jurisdiction (DE 1, at 2-3). On November 1, 2016, plaintiffs filed a motion to remand (DE 22), challenging this Court's jurisdiction. The issues have been sufficiently briefed by both parties and a hearing is not necessary.

         This case involves the plaintiffs' use of a permanent birth control device called “Essure.” Plaintiff Wolford and Taylor both underwent surgery at PMC to have the Essure device implanted, Wolford in 2014 and Taylor in 2013. Both plaintiffs allege that PMC failed to properly inform them of the risks associated with the device, and failed to use reasonable care in implanting the device (DE 1-1). Both plaintiffs allege that they suffered damages following their Essure implantation, including device migration, pain, and subsequent surgeries (DE 1-1). In September of 2014, Plaintiff Taylor learned that she was pregnant and underwent a cesarean section in May of 2015. (DE 1-1, 93).

         The plaintiffs contend that the device was originally created by Conceptus, Inc., a company bought by Bayer in 2013 (DE 22-1, at 5). In 2002, Essure was granted pre-market approval as a Class III medical device by the Food and Drug Administration, pursuant to the Medical Device Amendments to the Federal Food, Drug, and Cosmetic Act (DE 8-6, at 2). The plaintiffs do not attack the pre-market approval process. Instead, the plaintiffs allege the Bayer defendants failed to conform to FDA requirements regarding post-market monitoring of the device (DE 22-1, at 9). As a specific example of this conduct, plaintiffs allege that Conceptus, subsequently purchased by Bayer, failed to report to the FDA adverse effects that were discovered once Essure became widely used in the market, despite having an affirmative duty to do so (DE 22-1, at 9). Plaintiffs allege that these actions constitute a violation of various state tort laws and that, without the violations, the plaintiffs would never have used the device (DE 1-1).

         II. Analysis

         Although several motions are pending in this matter, the Court must first determine whether removal from Pike County Circuit Court was proper. Under 28 U.S.C. § 1441(a), the defendants may remove this case to federal court if they could have originally brought it here. On a motion to remand, the burden rests with the defendant to prove that this Court has original jurisdiction. Eastman v. Marine Mech. Corp., 438 F.3d 544, 549 (6th Cir. 2006). Original jurisdiction exists through either diversity of citizenship, see 28 U.S.C. §§ 1332(a) and 1441(b), or federal question jurisdiction, see 28 U.S.C. §§ 1331 and 1441(a). When doubts as to the appropriateness of removal exist, “the removal statute should be strictly construed and all doubts resolved in favor of remand.” Eastman, 438 F.3d at 550. The Court considers the parties' arguments on jurisdiction below.

         A. Federal Question Jurisdiction

         Courts have consistently applied the “well-pleaded complaint” rule when reviewing federal question jurisdiction on a motion to remand. “To determine whether the claim arises under federal law, we examine the ‘well pleaded' allegations of the complaint and ignore potential defenses[.]” Mikuslki v. Centerior Energy Corp., 501 F.3d 555, 560 (2007) (quoting Beneficial Nat'l Bank v. Anderson, 539 U.S. 1, 6 (2003)). As a result of the rule, “federal questions presented by defenses-or even by the plaintiff's anticipatory rebuttal of an expected defense-cannot support jurisdiction.” Dillon v. Medtronic, Inc., 992 F.Supp.2d 751, 755 (2014) (citing Franchise Tax Bd. v. Constr. Laborers Vacation Trust, 463 U.S. 1, 10 (1983)). “So, with only rare exception, a dispute over whether federal law trumps the plaintiff's state cause of action does not satisfy § 1331, since preemption is usually raised as a defense.” Id. (citing Caterpillar Inc. v. Williams, 482 U.S. 386, 393 (1987). “'[R]emoval and preemption are two distinct concepts, ' and the fact that plaintiffs' claim might ultimately prove to be preempted does not establish that it is removable to federal court.” Strong v. Telectronics Pacing Systems, Inc., 78 F.3d 256, 261 (6th Cir. 1996) (quoting Warner v. Ford Motor Co., 46 F.3d 531 (6th Cir. 1995).

         In this case, plaintiffs do not rely on a federal cause of action within their complaint. Instead, plaintiffs assert various state-law tort claims against the defendants. See (DE 1-1, Pl. Complaint); see also (DE 22-1, Pl. Mem. in Support of Mtn. to Remand, at 15-16). As such, the claims within the well-pleaded complaint do not directly arise under federal law or jurisdiction. The United States Court of Appeals for the Sixth Circuit, however, acknowledges three exceptions to the well-pleaded complaint rule, by which the defendants could still show that federal jurisdiction is proper. See Mikulski, 501 F.3d at 560. The first two exceptions, artful-pleading and complete preemption, are inapplicable in this case. Only the third exception, the substantial federal question doctrine, is at issue.

         i. The doctrines of artful pleading and complete preemption

         Under the artful pleading doctrine, a plaintiff may not “avoid removal jurisdiction by artfully casting their essentially federal law claims as state-law claims.” Mikuslki, 501 F.3d at 560. By its very nature, the artful pleading doctrine requires there first to be a federal cause of action that the plaintiff is trying to avoid-one that might have been invoked absent artful pleading. See Id. at 561-563. In this case, Congress has provided no private right of action under the FDCA, meaning the plaintiffs never had a federal claim to artfully plead around. 21 U.S.C. § 337(a).

         Related to the artful pleading doctrine, removal under complete preemption “is proper ‘when a federal statute wholly displaces the state-law cause of action[.]'” Id. (citing Federated Dep't Stores, Inc. v. Moitie, 452 U.S. 394, 397 (1981)). Thus far, complete preemption has been limited to three classes of cases by the Supreme Court: Section 301 of the Labor Management Relations Act of 1947; the Employee Retirement Income Security Act of 1975; and the National Bank Act. Mikulski, 501 F.3d at 563-564. Further, the Sixth Circuit has specifically declined to extend the doctrine to the Medical Device Amendments of the FDCA. See Strong, 78 F.3d at 259. As such, it is not applicable in this case.

         ii. The substantial federal question doctrine

         The remaining exception to the well-pleaded complaint rule is the substantial federal question doctrine. While a canvassing of the case law is necessary, the United States Supreme Court distilled the essence of the doctrine in Grable & Sons Metal Products, Inc., v. Darue Engineering & Manufacturing, 545 U.S. 308 (2005). In that case, a former landowner brought a quiet title action under state law against a tax sale purchaser, alleging the Internal Revenue Service had given him inadequate notice of sale. Id. After removal, the Court found federal jurisdiction existed because the meaning of the federal statute requiring notice was at issue; the Government had a strong interest in prompt and certain collection of delinquent taxes; and there would be a microscopic effect on the federal-state division of labor if federal jurisdiction was exercised. Grable, 545 U.S. at 314-315.

         Reciting the Supreme Court's decision in Grable, the Sixth Circuit has followed a three-part test when deciding if state-law claims implicate federal question jurisdiction:

(1) The state-law claim must necessarily raise a disputed federal issue; (2) the federal interest in the issue must be substantial; and (3) the exercise of jurisdiction must not disturb any congressionally approved balance of federal and state judicial responsibilities.

Mikuslki, 501 F.3d at 568. In another case, Gunn v. Miton, 568 U.S. 251, 258 (2013) the Supreme Court provide more guidance as to the substantial federal question doctrine describing the doctrine as applying only to a “special and small category of cases.” As to the second element cited above, substantiality, the Supreme Court concluded that “it is not enough that the federal issue be significant to the particular parties, ” but must be an important issue “to the federal system as a whole.” Gunn, 568 U.S. at 260.

         The Sixth Circuit has also weighed in on the element of substantiality, reciting four considerations:

(1) Whether the case includes a federal agency, and particularly, whether that agency's compliance with the federal statute is in dispute; (2) whether the federal question is important (i.e., not trivial); (3) whether a decision on the federal question will resolve the case (i.e. the federal question is not merely incidental to the outcome); and (4) whether a decision as to the federal question will control numerous other cases.

Mikuslki, 501 F.3d at 570.

         Although prior to both Grable and Gunn, another Supreme Court case is helpful in our analysis. In Merrell Dow Pharmaceuticals Inc., v. Thompson,478 U.S. 804 (1986), the Court considered common law tort claims against a drug manufacturer that had been removed to federal court. As part of the common law claims, “[plaintiffs] alleged that the drug Bendectin was ‘misbranded' in violation of the [FDCA]…because its labeling did not provide adequate warning that its use was potentially ...

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